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4.
2016. Pharma Marketing Network. All rights reserved.
Path Taken by Sarepta NOT a Good
Model for Other Rare Drug Approvals
In a presentation at a summit meeting of
the National Organization of Rare
Diseases on Tuesday, October 16, 2016,
John Jenkins, director of the office of new
drugs at the Center for Drug Evaluation
and Research, singled out the eteplirsen
case as a new textbook example of what
other companies should avoid.
http://sco.lt/7stCs5
A few weeks later, CDER director and
Sarepta champion Janet Woodcock
spread the word that Jenkins is retiring
from the FDA in early January — and
she’s temporarily assuming his position.
http://sco.lt/8CkEpl

6.
2016. Pharma Marketing Network. All rights reserved.
Cost to Bring a New Drug to Market is
Increasing – Or Is It?
Tufts revised its estimate of the cost
to bring a new drug to market to be
$2.6 billion, which is 3.25 times its
widely quoted 2003 estimate of
$800 million. Meanwhile, the
London School of Economics and
political Sciences (LSEPS) suggests
this number is highly inflated, even
if you take out the “cost of capital,”
which is not real money spent by
pharma.
http://bit.ly/newtufts

7.
2016. Pharma Marketing Network. All rights reserved.
Wide Range of R&D Cost Estimates
In September, 2016, the United
Nations released a report urging
governments to take various steps to
ensure greater access to needed
medicines. The report claims that not
enough is being done to develop
drugs to treat diseases that pre-
dominantly afflict poor populations.
The Pharmaceutical Research &
Manufacturers of America was not
pleased, though. The industry trade
group called the report a “a missed
opportunity to address the wide array
of barriers to access that far too many
people face every day.”
http://sco.lt/6znt6v

8.
2016. Pharma Marketing Network. All rights reserved.
Vaccines Are Path to Revenue Growth
The revenue growth opportunity in
vaccines looks far more promising
when compared to the overall
market for pharmaceuticals.
Revenues earned by vaccines
manufacturers worldwide reached
$27.6 billion in 2015 according to
Kalorama Information, up 11% from
$24.7 billion in 2014, as sales in all
segments expanded.
http://sco.lt/582wTZ

14.
2016. Pharma Marketing Network. All rights reserved.
The Boom in DTC TV Advertising!
The portion of DTC
spending on TV has
increased from 55% in
2011 to 69% in 2015.
Will this boom
continue?
Most likely, yes! Read:
“Big Pharma Spending
on TV Ads Like a
Drunken Sailor.”
http://sco.lt/8epI6z

15.
2016. Pharma Marketing Network. All rights reserved.
Top 10 Rx TV Ad Spends
Pfizer owned TV ad
spending for 2015
among pharma brands.
It took 5 spots on the
top 10 list for the year,
including Nos. 1 and 2,
according to iSpot.tv.
http://sco.lt/8KZEAb

19.
2016. Pharma Marketing Network. All rights reserved.
The Pain in Spain: Naked Celebrities Promote Oxycontin
Prescriptions for OxyContin have fallen nearly
40% since 2010. So the company’s owners,
the Sackler family, are pursuing a new
strategy: Put the painkiller that set off the
U.S. opioid crisis into medicine cabinets
around the world.
In this global drive, the companies, known as
Mundipharma, are using some of the same
controversial marketing practices that made
OxyContin a pharmaceutical blockbuster in
the U.S. Seeking new patients in Spain, for
example, Mundipharma chose ambassadors
guaranteed to attract attention: Naked
celebrities.
http://sco.lt/8LFSuv

20.
2016. Pharma Marketing Network. All rights reserved.
Questions About FDA Regulation of EpiPen Competition
Five US senators wrote the FDA to
express concerns the agency may
have helped stifle EpiPen
competition. And in their letter to
FDA Commissioner Dr. Robert Califf,
the lawmakers worry the FDA is not
doing enough to ensure that
competitive versions are available,
especially given that epinephrine -
the main ingredient in EpiPen - has
been on a drug shortage list since
2012.
Find the list of questions here:
http://sco.lt/6RgsUb

21.
2016. Pharma Marketing Network. All rights reserved.
Tracking Who Makes Money On A Brand-Name Drug
Kaiser Health News joined forces
with USA Today to create this chart,
which details the various industry
players and how they contribute to
a prescription drug’ s cost.
See the entire chart here...
http://sco.lt/7h31Ht
No matter what the "middlemen"
make, drug price INCREASES start
at the top; i.e., the drug company.

22.
2016. Pharma Marketing Network. All rights reserved.
Content Channel Value as Seen by Docs vs. Pharma
A study by EPG Health Media, publisher of
epgonline.org (a website for healthcare
professionals) found some "significant gaps and
imbalances" between how healthcare
professionals (HCPs) and pharma industry
professionals (Pharma) view the value of
medical content delivery channels.
For example, pharma professionals think rep
visits are much more valuable sources of
medical information than do HCPs and HCPs
believe medical apps may be important content
sources, but not as valuable as pharma
professionals think they are.
But there are some devils in the details.
http://sco.lt/6c7IcD

26.
2016. Pharma Marketing Network. All rights reserved.
Growth/Decline in Pharma Support of CME
The total commercial (i.e., pharma)
support of accredited continuing
medical education was $1.08 billion in
2015 – a 5.2% increase over 2015.
Perhaps the pharma industry was
anticipating that the 21st Cures Act
would exclude CME payments from the
reporting requirements of the Sunshine
Law. Alas, that provision did not make
in the final version that the Senate sent
to the present in December 2016.
Or perhaps the industry has just
learned to live with the sunshine and
really, really needs to educate
physicians about all the new and
complex drugs being approved by the
FDA these days.
http://sco.lt/7yzXl3

27.
2016. Pharma Marketing Network. All rights reserved.
Last Minute Uptick in FDA Letters for 2016
FDA’s Office of Prescription Drug
Promotion is dredging the
bottom of the barrel and issued 6
enforcement letters in the last
weeks of December, 2016 to
bring the total to 11 for the year.
All this smacks of getting some
last licks in before a new FDA
commissioner takes over.
http://sco.lt/6HUSgL

28.
2016. Pharma Marketing Network. All rights reserved.
FDA Enforcement vs. PDUFA Fees
Research suggests that drugs
released after the 1992 enactment
of the Prescription Drug User Fee
Act (PDUFA), which allowed the FDA
to collect fees to expedite drug
approvals, were more likely to be
withdrawn or have a black box
warning.
As this chart shows, as FDA collects
more fees, it issues fewer enforce-
ment letters. Coincidence?
http://sco.lt/8CCwW9

29.
2016. Pharma Marketing Network. All rights reserved.
Dramatic Increase in Drug Adverse Events
In 2014 more AERs were
submitted by consumers
than by Health Care
Professionals (HCPs) of
all types. Not only is the
FDA receiving more
AERs every year, the
number of serious AEs
and AEs involving death
are also increasing
dramatically.
http://sco.lt/8pXZD7

30.
2016. Pharma Marketing Network. All rights reserved.
FDA User Fees & the Increase in Serious AERs
I decided to plot the
number of AERs
involving serious side
effects along with the
rise in user fees
collected by the FDA
from pharma companies
and came up with this
chart. Of course, this
does not prove a
correlation between
PDUFA fees and serious
AERs, but…
http://sco.lt/8pXZD
7

33.
2016. Pharma Marketing Network. All rights reserved.
Pharma Criminal & Civil Penalty Challenge
In a March, 2016, report, Public Citizen tallied all
drug industry settlements with both federal and
state governments from 1991 through 2015.
When readers of Pharma Marketing Blog were
challenged to rank the Top 10 of those companies
in terms of the amount paid over those 10 years,
only one person was able to do so. The correct
rank of each company is circled in this chart of
response results.
Some surprises: Only 5% of respondents correctly
ranked AZ last whereas 31% thought it ranked in
the top 3. 21% of respondents correctly ranked
J&J as #3, but that may because I gave hints along
the way via Twitter. 70% of respondents ranked
Teva as #9 or #10 and only 9% correctly ranked it
as #7 on the list.
http://sco.lt/6z3eAD

34.
2016. Pharma Marketing Network. All rights reserved.
Social Media & the Written Word
Here is a breakdown of the current stats relating to
my Internet publishing activities over the years:
Pharma Marketing News (started January 2002)
• 639 articles
• Over 1.2 million words (1800 words per article)
Pharma Marketing Blog (started January 2005)
2393 posts
• Over 2.3 million words (554 words per post)
Pharmaguy on Twitter (started March 2008)
• Over 26,000 tweets
• Over 0.5 million words (21 words per tweet)
Do you see the trend?
http://sco.lt/6kdu1B